IMPLANT INSERTERS AND RELATED METHODS

Abstract

Implant inserters and related methods are disclosed herein, e.g., for delivering a fusion cage or other implant to a spinal disc space and for rotating or articulating the implant within the disc space. An exemplary instrument can include a slider that is slidably mounted to a body to define an implant clamp. A locking mechanism can allow the slider to be quickly disassembled from the body and for fast and convenient loading and unloading of an implant to the instrument. An actuation knob can be moved between a first position in which the implant is locked from rotating relative to the instrument and a second position in which the implant is retained to the instrument but allowed to rotate relative to the instrument.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No. 62/534,039, filed Jul. 18, 2017, the entire contents of which are incorporated herein by reference.

FIELD

Implant inserters and related methods are disclosed herein, e.g., for delivering a fusion cage or other implant to a spinal disc space and for rotating or articulating the implant within the disc space.

BACKGROUND

There are a number of surgical procedures in which an implant is delivered to a location within a patient. In spine surgery, for example, a fusion cage, disc prosthesis, or other implant may be delivered to a disc space defined between two vertebrae. Insertion and proper positioning of the implant can be challenging for the surgeon, particularly when the implant is delivered through a narrow working channel, e.g., in the case of minimally-invasive approaches to the spine.

By way of further example, in some procedures it can be necessary to insert an implant in a first orientation and subsequently manipulate the implant into a second orientation after insertion. When inserting through a narrow working channel, for example, it can be necessary to insert an implant such that its smallest cross-sectional area faces distally or in the direction of insertion. Once through a narrow working channel and within a patient, however, it can be necessary to manipulate the implant into a different orientation for optimal or intended performance. In some cases, it can also be desirable to perform such manipulation of an implant without releasing the implant from an inserter in case additional manipulation, removal, or other revision is required to properly position the implant.

Accordingly, there is a need for improved implant inserters and related methods that can facilitate insertion and proper positioning of an implant within a patient.

SUMMARY

Implant inserters and related methods are disclosed herein, e.g., for delivering a fusion cage or other implant to a spinal disc space and for rotating or articulating the implant within the disc space. An exemplary instrument can include a slider that is slidably mounted to a body to define an implant clamp. A locking mechanism can allow the slider to be quickly disassembled from the body and for fast and convenient loading and unloading of an implant to the instrument. An actuation knob can be moved between a first position in which the implant is locked from rotating relative to the instrument and a second position in which the implant is retained to the instrument but allowed to rotate relative to the instrument.

In one aspect, a surgical instrument is provided that includes a proximal end, a distal end, a central longitudinal axis extending between the proximal and distal ends, a body, a slider coupled to the body. The body and the slider collectively define an implant clamp at the distal end of the instrument. The instrument further includes an actuation knob movable between a first position in which the clamp is configured to retain an implant to the instrument without allowing the implant to rotate relative to the instrument and a second position in which the clamp is configured to retain an implant to the instrument while allowing the implant to rotate relative to the instrument.

The devices and methods described herein can have a number of additional features and/or variations, all of which are within the scope of the present disclosure. In some embodiments, for example, the clamp can be configured to selectively allow rotation of the implant about a rotation axis that is perpendicular to the central longitudinal axis. In some embodiments, the instrument can further include a handle extending from the body such that a central longitudinal axis of the handle is transverse to the central longitudinal axis of the instrument. In such embodiments, the rotation axis can be perpendicular to a plane defined by the central longitudinal axis of the instrument and the central longitudinal axis of the handle.

In certain embodiments, the instrument can further include a locking shaft coupled to a proximal end of the slider, and a proximal end of the locking shaft can include a groove formed therein and a central portion of the locking shaft can include exterior threads formed thereon. Further, the locking shaft can be received within a first bore formed in the body. In some embodiments, the actuation knob can include a central opening having interior threads that mate with the exterior threads formed on the locking shaft.

In other embodiments, the instrument can further include an actuator disposed within a second bore formed in the body and configured to move between a first position to couple the locking shaft to the body and a second position to release the locking shaft from the body. In some embodiments, the actuator can be biased toward the first position. In certain embodiments, the actuator can be configured to couple the locking shaft to the body by disposing a portion thereof within the groove formed in the locking shaft. Further, the groove in the locking shaft can be sized such that some degree of proximal and distal translation of the locking shaft relative to the actuator and the body is possible when the actuator is in the first position.

In another aspect, a surgical method is provided that includes coupling an implant to an inserter such that the implant cannot rotate relative to the inserter and passing the implant through a working channel to a surgical site. The method also includes configuring the inserter to allow rotation of the implant relative to the inserter while still retaining the implant to the inserter, articulating the implant while retained to the inserter, and releasing the implant from the inserter.

As with the above-described aspect, a number of additional features and/or variations can be included, all of which are within the scope of the present disclosure. In some embodiments, for example, coupling the implant to the inserter can include moving an actuator of the inserter from a first position to a second position to allow a slider of the inserter to be withdrawn proximally relative to a body of the inserter and thereby open an implant clamp of the inserter defined by distal ends of the slider and the body.

In some embodiments, coupling the implant to the inserter can further include placing a portion of the implant within the implant clamp, advancing the slider distally relative to the body to close the implant clamp around the portion of the implant, moving the actuator to the first position to limit movement of the slider relative to the body, and rotating an actuation knob in a first direction to further advance the slider distally and lock the rotational position of the implant relative to the inserter.

In certain embodiments, configuring the inserter to allow rotation of the implant relative to the inserter while still retaining the implant to the inserter can include rotating the actuation knob in a second direction to retract the slider proximally relative to the body. Further, releasing the implant from the inserter can in some embodiments include moving the actuator from the first position to the second position and retracting the slider proximally relative to the body to open the implant clamp.

In another aspect, a surgical instrument is provided that includes a body having an elongate distal portion and a handle extending from a proximal portion of the body, as well as a slider coupled to the body and extending parallel to the elongate distal portion of the body. Distal ends of the slider and the body can collectively define an implant clamp. The instrument can further include a locking shaft coupled to a proximal end of the slider and received within a first bore formed in the proximal portion of the body, as well as a first actuator disposed within a second bore formed in the proximal portion of the body. The first actuator can be configured to selectively limit proximal and distal translation of the slider relative to the body. The instrument can further include a second actuator disposed about the locking shaft that is also configured to limit proximal and distal translation of the slider relative to the body. The first actuator and the second actuator can be configured to selectively retain an implant within the implant clamp and selectively allow rotation of the implant relative to the instrument.

In some embodiments, the clamp can be configured to selectively allow rotation of the implant about a rotation axis that is perpendicular to a central longitudinal axis of the instrument extending between a proximal end of the body and the distal end of the body. In certain embodiments, the handle can extend from the proximal portion of the body such that a central longitudinal axis of the handle is transverse to the central longitudinal axis of the instrument, and the rotation axis can be perpendicular to a plane defined by the central longitudinal axis of the instrument and the central longitudinal axis of the handle.

In some embodiments, the second actuator can be a knob including a central opening having interior threads that mate with the exterior threads formed on the locking shaft.

Any of the features or variations described above can be applied to any particular aspect or embodiment of the present disclosure in a number of different combinations. The absence of explicit recitation of any particular combination is due solely to the avoidance of repetition in this summary.

BRIEF DESCRIPTION OF THE DRAWINGS

The aspects and embodiments described above will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1 illustrates a perspective view of one embodiment of an implant inserter;

FIG. 2 illustrates side cross-sectional view of the implant inserter of FIG. 1;

FIG. 3 illustrates a side view of the implant inserter of FIG. 1;

FIG. 4 illustrates a side view of the implant inserter of FIG. 1 in a disassembled state;

FIG. 5 illustrates a side view of the implant inserter of FIG. 1 in an implant receiving state;

FIG. 6 illustrates a side view of the implant inserter of FIG. 1 with an implant retained thereto;

FIG. 7 illustrates a side view of the implant inserter of FIG. 1 with an implant articulated or rotated relative thereto;

FIG. 8 illustrates an alternative view of the implant inserter of FIG. 1 with the implant articulated or rotated relative thereto;

FIG. 9 illustrates a side view of the implant inserter of FIG. 1 releasing an implant;

FIG. 10 illustrates an alternative side view of the implant inserter of FIG. 1;

FIG. 11 illustrates a detail view of a portion of the implant inserter circled A in FIG. 12;

FIG. 12 illustrates an alternative perspective view of the implant inserter of FIG. 1;

FIG. 13 illustrates a perspective view of the slider, locking shaft, and actuation knob of the implant inserter of FIG. 1;

FIG. 14 is a top view of the components of FIG. 13;

FIG. 15 is a side view of the components of FIG. 13;

FIG. 16 is a cross-sectional view of the coupling between the slider and the locking shaft taken along the line A-A shown in FIG. 15;

FIG. 17 is a cross-sectional view of the body, handle, and push button of the implant inserter of FIG. 1 taken along the line A-A shown in FIG. 19;

FIG. 18 is a cross-sectional view of the components of FIG. 17 taken along the line B-B shown in FIG. 17;

FIG. 19 is a bottom view of the body and handle of the implant inserter of FIG. 1;

FIG. 20 is a perspective view of the body and handle of the implant inserter of FIG. 1;

FIG. 21 is a top view of the body of the implant inserter of FIG. 1;

FIG. 22 is a cross-sectional view of the body of the implant inserter of FIG. 1 taken along the line A-A shown in FIG. 23;

FIG. 23 is a bottom view of the body of the implant inserter of FIG. 1;

FIG. 24 is a cross-sectional view of the body of the implant inserter of FIG. 1 taken along the line D-D shown in FIG. 21;

FIG. 25 is a cross-sectional view of the body of the implant inserter of FIG. 1 taken along the line B-B shown in FIG. 22;

FIG. 26 is a perspective view of the body of the implant inserter of FIG. 1;

FIG. 27 is a perspective view of the slider of the implant inserter of FIG. 1;

FIG. 28 is a cross-sectional view of the slider of the implant inserter of FIG. 1 taken along the line G-G shown in FIG. 31;

FIG. 29 is a cross-sectional view of the slider of the implant inserter of FIG. 1 taken along the line A-A shown in FIG. 31;

FIG. 30 is a cross-sectional view of the slider of the implant inserter of FIG. 1 taken along the line B-B shown in FIG. 31;

FIG. 31 is a bottom view of the slider of the implant inserter of FIG. 1;

FIG. 32 is a rear view of the slider of the implant inserter of FIG. 1;

FIG. 33 is a cross-sectional view of the slider of the implant inserter of FIG. 1 taken along the line D-D shown in FIG. 31;

FIG. 34 is a detail cross-sectional view of the portion of the slider circled C in FIG. 29;

FIG. 35 is a detail view of the portion of the slider circled E in FIG. 29;

FIG. 36 is a detail view of the portion of the slider circled F in FIG. 31;

FIG. 37 is a perspective view of the handle of the implant inserter of FIG. 1;

FIG. 38 is a top view of the locking shaft of the implant inserter of FIG. 1;

FIG. 39 is a perspective view of the locking shaft of the implant inserter of FIG. 1;

FIG. 40 is a side view of the locking shaft of the implant inserter of FIG. 1;

FIG. 41 is a cross-sectional view of the actuation knob of the implant inserter of FIG. 1 taken along the line A-A shown in FIG. 43;

FIG. 42 is a perspective view of the actuation knob of the implant inserter of FIG. 1;

FIG. 43 is a side view of the actuation knob of the implant inserter of FIG. 1;

FIG. 44 is a front view of the push button of the implant inserter of FIG. 1;

FIG. 45 is a side view of the push button of the implant inserter of FIG. 1;

FIG. 46 is a cross-sectional view of the push button of the implant inserter of FIG. 1 taken along the line A-A shown in FIG. 45;

FIG. 47 is a cross-sectional view of the push button of the implant inserter of FIG. 1 taken along the line B-B shown in FIG. 44;

FIG. 48 is a perspective view of the push button of the implant inserter of FIG. 1;

FIG. 49 is a perspective view of the spring of the implant inserter of FIG. 1;

FIG. 50 is a perspective view of the first pin of the implant inserter of FIG. 1;

FIG. 51 is a perspective view of the second pin of the implant inserter of FIG. 1; and

FIG. 52 illustrates an exemplary implant that can be inserted using the implant inserter.

DETAILED DESCRIPTION

Implant inserters and related methods are disclosed herein, e.g., for delivering a fusion cage or other implant to a spinal disc space and for rotating or articulating the implant within the disc space. An exemplary instrument can include a slider that is slidably mounted to a body to define an implant clamp. A locking mechanism can allow the slider to be quickly disassembled from the body and for fast and convenient loading and unloading of an implant to the instrument. An actuation knob can be moved between a first position in which the implant is locked from rotating relative to the instrument and a second position in which the implant is retained to the instrument but allowed to rotate relative to the instrument.

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the instruments and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the instruments and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments.

FIGS. 1-3 illustrate an exemplary implant inserter instrument 100. The instrument 100 can be used to insert an implant into a target location within a patient, such as a spinal disc space. The instrument 100 can be used to articulate or rotate the implant, or to allow the implant to be articulated or rotated, while the implant is disposed in the target location, or as the implant is delivered to the target location. The instrument 100 can allow the implant to rotate relative to the instrument while the implant remains captured or retained by the instrument. Exemplary implants with which the instrument 100 can be used include the T-PAL TLIF spacer available from DEPUY SYNTHES SPINE of Raynham, Mass. An example of this implant 5200 is shown in FIG. 52.

The instrument 100 can include a body 102 that extends from a proximal end 102p to a distal end 102d along a central longitudinal axis A1 of the instrument 100. The body 102 can include a handle or grip 104 extending therefrom. A slider 106 can be slidably coupled to the body 102 such that the slider can translate along the axis A1 relative to the body. The distal ends of the slider 106 and the body 102 can collectively define an implant clamp 108 configured to selectively grasp, capture, and/or retain an implant. The clamp 108 can be configured to selectively hold an implant while permitting articulation of the implant about an axis A2. The axis A2 can be perpendicular to the axis A1 and can extend between superior and inferior bone-contacting surfaces of the implant.

The proximal end of the slider 106 can be coupled to the body 102 via a locking mechanism 109. The locking mechanism 109 can have a first position in which the locking mechanism does not restrict axial translation of the slider 106 relative to the body 102, and a second position in which the locking mechanism limits axial translation of the slider relative to the body. The locking mechanism 109 can include a push button or other actuator 110 biased by a spring or other biasing element 112 and a locking shaft 114 disposed through an aperture formed in the button. The locking shaft 114 can be pivotally coupled to the slider 106 by a first pin 116. The button 110 can be slidably retained to the body 102 by a second pin 118. Pressing the button 110 into the body 102 against the bias of the spring 112 can move the button out of engagement with a groove 120 formed in the locking shaft 114, allowing the shaft and the slider 106 to translate axially or proximally/distally relative to the button and the body. Releasing the button 110 can allow the button to return under the bias of the spring 112 into engagement with the groove 120 formed in the shaft 114 to limit axial translation of the shaft and the slider 106 relative to the button and the body 102.

The instrument 100 can include an actuation knob or other actuator 122. The actuation knob 122 can be mounted to the locking shaft 114. For example, the actuation knob 122 can define a central opening having interior threads that mate with exterior threads formed on the locking shaft 114. As described further below, the actuation knob 122 can be movable along the locking shaft 114 between a first position in which an implant disposed in the clamp 108 is locked from rotating relative to the instrument 100 about the axis A2 and a second position in which such an implant is retained to the instrument but allowed to rotate relative to the instrument about the axis A2.

As shown in FIG. 4, the instrument 100 can be disassembled, e.g., for cleaning or sterilization. To disassemble the instrument 100, the actuation knob 122 can be rotated relative to the locking shaft 114 to move the knob along the locking shaft to a distal position. The button 110 can be depressed and the locking shaft 114 can be pulled distally out of the button and the body 102. The slider 106 can pivot about the first pin 116 to separate the slider from the body 102. The instrument 100 can thus be divided into a slider sub-assembly, e.g., including the slider 106, the locking shaft 114, and the actuation knob 122, and a body sub-assembly, e.g., including the body 102, the grip 104, the button 110, and the spring 112.

As shown in FIG. 5, the instrument 100 can be positioned in an implant loading configuration in which it is prepared to receive an implant in the clamp 108. To position the instrument 100 in this configuration, the button 110 can be depressed to allow the slider sub-assembly to translate axially or proximally/distally relative to the body 102. The actuation knob 122 can then be pulled proximally to translate the slider 106 relative to the body 102 along the axis A1, thereby opening the implant clamp 108, i.e., positioning the distal end of the slider 106 far enough proximally to permit a portion of an implant to be received within a concave distal portion of the body 102. For example, the illustrated implant 5200 of FIG. 52 includes a first surface 5202 and a second surface 5204 separated from one another. A post 5206 extends between the two surfaces and can be configured to be received or surrounded by the implant clamp 108 to couple the implant to the instrument 100. As shown in FIG. 52, the post 5206 can include a plurality of flat surfaces arranged around its circumference and, in some embodiments, these surfaces can be aid in the selective prevention of rotation of the implant relative to the instrument by, for example, including one or more corresponding flat surfaces on distal ends of any of the body 102 or slider 106 such that a flat surface of the instrument can be abutted against a flat surface of the implant to prevent relative movement therebetween. In other embodiments, however, curved surfaces can be utilized in any of the implant, body, and slider.

As shown in FIG. 6, once an implant (e.g., implant 5200) is positioned within the clamp 108, the slider 106 can be translated distally relative to the body 102 along the axis A1 to capture the implant within the clamp 108. In this configuration, the button 110 can be released such that the button engages the groove 120 formed on the locking shaft 114 to limit proximal movement of the slider 106 relative to the body 102 and to thereby retain the implant within the clamp 108.

As shown in FIGS. 6-7, the implant can be selectively permitted to rotate relative to the instrument 100 about the axis A2 when the implant is retained within the clamp 108. In particular, as shown in FIG. 6, the actuation knob 122 can be disposed in a first, proximal position in which an implant disposed in the clamp 108 is locked from rotating relative to the instrument 100 about the axis A2. To lock the implant from rotating relative to the instrument 100, the actuation knob 122 can be disposed in a proximal position on the locking shaft 114 in which the actuation knob abuts the body 102 to interfere with proximal translation of the slider 106 relative to the body. With the slider 106 urged distally and prevented from translating proximally, the implant can be firmly clamped to the instrument 100 such that the implant cannot rotate relative to the instrument about the axis A2. As shown in FIG. 7, the actuation knob 122 can be disposed in a second, distal position in which an implant disposed in the clamp 108 is retained to the instrument 100 but allowed to rotate relative to the instrument about the axis A2. The actuation knob 122 can be disposed in a distal position in which the actuation knob does not interfere with proximal translation of the slider 106 relative to the body 102. The groove 120 formed in the locking shaft 114 can be oversized in the proximal-distal direction relative to the engagement features of the button 110, such that some proximal movement of the slider 106 relative to the body 102 is permitted to allow articulation of the implant. The relative geometries of the button 110 and the groove 120, however, can be such that proximal translation of the slider 106 relative to the body 102 is not permitted to a degree that would allow the implant to separate from the instrument 100. As shown in FIG. 8, the instrument 100 can be configured such that a high degree of rotation of the implant about the axis A2 is permitted.

As shown in FIG. 9, the instrument 100 can be disconnected from the implant, e.g., once the implant is placed as desired within the patient. The instrument 100 can be separated from the implant by pressing the button 110 and pulling the actuation knob 122 proximally to translate the slider 106 proximally relative to the body 102 and thereby open the clamp 108, similar to the configuration shown in FIG. 5 for loading the implant prior to insertion into a patient.

FIGS. 10-51 illustrate detailed views of the various components of the instrument 100. FIG. 52 illustrates an exemplary implant that can be used with the instrument 100.

FIGS. 10-12, for example, show detailed side views of the instrument 100, including the proximal portion of the boxy 102. In these figures, the actuation knob 122 is shown positioned distally beyond the pivot positioning marker 1002. When the knob is in such a position and the button 110 is depressed, the slider 106 can be advanced distally and rotated about pin 116 away from the body 102, as shown in FIG. 4. Conversely, when full locking of the implant within the clamp 108 is desired, the actuation knob 122 can be positioned proximally such that it abuts against the body 102 and is in line with the lock positioning marker 1004.

FIGS. 13-16 illustrate the above-mentioned slider sub-assembly 1300, which can include the slider 106, locking shaft 114, pin 116, and actuation knob 122. The slider 106 can be coupled to the locking shaft 114 using a clevis joint, e.g., with a proximal end of the slider 106 forming a U-shaped clevis with opposed arms 1402, 1404 that receive a tang 1406 formed at a distal end of the locking shaft 114. The components can be held together by the pin 116 such that they can pivot about the pin's longitudinal axis but cannot rotate relative to one another about a central longitudinal axis of the slider or locking shaft.

The slider 106 can include a distal end 1408 configured to form part of the clamp 108, as well as distal guide surfaces 1302, 1304 configured to ride along the sides of an elongate distal portion of the body 102 to maintain alignment of the slider and the body. The slider 106 can also include one or more protrusions 1306, 1308 configured to be received within recesses formed in the body 102 to maintain alignment of the slider and the body and prevent inadvertent pivoting of the components away from one another. The protrusions 1306, 1308 can have any of a variety of shapes but in some embodiments can have a T-track or other shape that can be received through a larger opening and subsequently translated into a smaller opening to prevent separation but allow for translation between the slider and the body.

As noted above, the locking shaft 114 can include the groove 120 formed in a proximal portion thereof, as well as the aforementioned distal end 1406 configured to couple to the proximal end of the slider 106. A portion of the locking shaft 114 between the groove 120 and the distal end 1406 can have external threads 1310 formed thereon. The external threads 1310 can be configured to mate with threads formed on an internal surface of a central opening formed in the actuation knob 122 to allow rotation of the knob to control translation of the slider 106 relative to the body 102, as described herein.

FIGS. 17-20 illustrate the above-mentioned body subassembly 1700, which can include the body 102, grip or handle 104, button or other actuator 110, and spring or other biasing element 112. The grip or handle 104 can be coupled to the body 102 in a variety of manners, including via a threaded connection, a press fit interference connection, welding, adhesive, etc. The handle 104 can extend from the body 102 such that a longitudinal axis A3 of the handle is perpendicular to the central longitudinal axis A1 of the instrument. Alternatively, the handle 104 can be arranged to extend from at a different angle such that the axes A3 and A1 cross one another at an oblique angle.

The push button or other actuator 110 can be disposed in a first bore (see FIG. 21) formed in the body 102 along with the spring or other biasing element 112. The pin 118 can retain the button 110 within the first bore while allowing movement through a desired range of motion. As explained in more detail below, the button 110 can include an aperture formed therein that can at least partially align with a second bore formed in the body 102 to receive the locking shaft 114.

FIGS. 21-26 illustrate the body 102 in greater detail. A distal portion of the body 2106 can have a shape to receive a portion of an implant, such as the implant 5200 of FIG. 52. The portion 2106 can, for example, have a curved semi-circular shape that can receive a portion of an implant and, in connection with a correctly-positioned distal portion of the slider 106, retain the implant between the slider and the body.

The distal portion 2106 can be disposed at an end of an elongate distal portion 2104 of the body 102 that extends from a proximal portion 2102. Spaced along the elongate distal portion 2104 can be one or more apertures 2108, 2110 configured to receive the one or more protrusions 1306, 1308 formed on the slider 106. Each aperture, e.g., aperture 2108, can include a larger distal opening 2108a configured to receive the protrusion 1306 when the slider is pivoted into parallel alignment with the body 102, as well as a narrower proximal opening 2108b configured to receive only a narrower portion of the protrusion 1306 (e.g., when the protrusion has a T shape, etc.) to permit translation of the slider relative to the body while preventing the slider from pivoting away from the body. A cross-sectional view of a shoulder 2402 that can be used to achieve this effect is shown in FIG. 24.

Turning to the proximal portion 2102 of the body 102, FIGS. 21-26 illustrate the first bore 2112 that is configured to receive the push button 110 and spring 112. Also shown is the second bore 2202 that is configured to receive the locking shaft 114. The first and second bores 2112, 2202 cross one another such that the locking shaft 114 can extend through an aperture formed in the button 110. Also shown in the figures is a third bore 2204 formed in the body 102 and configured to receive an end of the handle or grip 104.

FIGS. 27-36 illustrate the slider 106 in greater detail. Visible features include the T-shaped protrusions 1306, 1308, the proximal clevis U-shaped arms 1402, 1404, the distal guides 1302, 1304, and the distal end 1408 described above. Of note in these figures is the fact that the guides 1302, 1304 can be configured to contact the portion of the implant disposed between distal ends of the slider 106 and the body 102 in the implant clamp 108. Accordingly, the guides 1302, 1304 can provide additional surface area for securely gripping the implant and preventing any relative movement, e.g., rotation, of the implant relative to the instrument 100 when in the locked configuration shown in FIG. 6.

FIG. 37 illustrates the grip or handle 104 in isolation, including a protrusion 3702 formed at one end thereof that can be configured to extend into the bore 2204 and be secured using any of a variety of techniques known in the art. Also shown is the central longitudinal axis A3 of the handle 104 that can be configured to extend from the instrument such that it is perpendicular to the central longitudinal axis of the instrument A1, as shown in FIG. 1. In other embodiments, however, the handle can be configured to extend at a different angle from the body 102 such that the axes A1, A3 are oblique to one another.

FIGS. 38-40 illustrate the locking shaft 114 in isolation. Visible in the figure are the above-described distal tang 1406, the proximal groove 120, and the intermediate portion having external threads 1310 formed thereon. As noted above, the groove 120 can have an oversize length L extending axially along the shaft to allow some degree of proximal/distal translation of the shaft relative to the body even when the button 110 is positioned so as to retain the shaft to the body 102.

FIGS. 41-43 illustrate the actuation knob 122 in isolation. As noted above, the actuation knob 122 can include a central opening 4102 formed therein and an internal surface of the opening can include threads 4104 formed thereon. The threads 4104 can be configured to mate with the external threads 1310 formed on the locking shaft 114, as described herein. An outer surface of the actuation knob 122 can include surface features to facilitate a user gripping and rotating the knob, such as surface knurling 4302 or other similar features.

FIGS. 44-48 illustrate various views of the push button or other actuator 110. The button 110 can include an aperture formed therethrough that can be configured to receive the locking shaft 114. The aperture can have a first circular diameter D₁ extending through an entire thickness of the button 110, as well as partial-thickness cut-outs extending from each end of the aperture having a larger elliptical shape with major diameter D₂ and a minor diameter of D₁. This can create an aperture or through-hole having a ridge 4404 extending into the aperture or through-hole 4402. The ridge 4404 can have a size configured to interface with the groove 120 formed in the locking shaft 114 such that, when the ridge 4404 is disposed within the groove 120, the locking shaft can only be moved proximally or distally until the ridge abuts one of a proximal or distal sidewall of the groove 120. Because the ridge is formed on the bottom of the aperture 4402, the biasing element 112 can urge the button 110 upward and urge the ridge 4404 into the groove 120 when a user releases the button 110. Conversely, when a user depresses the button 110 and disposes the locking shaft 114 in the upper portion of the aperture 4402 above the ridge 4404, the locking shaft 114 can be withdrawn from the aperture 4402.

The upward or downward travel of the button 110 can be limited by the pin 118 that can be disposed within a second aperture 4502 formed through the button 110. As shown, the second aperture 4502 is perpendicularly oriented relative to the aperture 4402, but in other embodiments a different configuration can be utilized. The second aperture 4502 can have an elliptical cross section with a major diameter that can define the range of movement for the button 110 (because the pin 118 can be stationary relative to the body 102 when disposed through apertures formed therein that substantially match the diameter of the pin). This dimension can be configured to substantially match, for example, a depth of the groove 120 and height of the ridge 4404 in some embodiments.

FIGS. 49-51 illustrate the spring 112 and pins 116, 118 in isolation. These components are known in the art, e.g., conventional coil springs and cylindrical pins. In some embodiments, any of a variety of alternatives known in the art can be substituted for the elements shown in these figures.

In use, the instrument 100 can be configured as shown in FIG. 4 and can be cleaned and/or sterilized to prepare the instrument for surgery. A fusion cage or other implant can be loaded onto the instrument 100 and locked in the position shown in FIG. 6. The instrument 100 can then be used to deliver the implant to a target site within a patient, for example by passing the implant into a spinal disc space through a minimally-invasive working channel and/or using a TLIF approach. Once the implant is disposed within the disc space, or at any other time desired by the user, the instrument 100 can be configured as shown in FIG. 7 and the implant can be rotated relative to the instrument about the axis A2, e.g., to either of the positions shown in FIGS. 7 and 8. The instrument 100 can then be disconnected from the implant as shown in FIG. 9, and the surgical procedure can be completed using known techniques.

It should be noted that any ordering of method steps expressed or implied in the description above or in the accompanying drawings is not to be construed as limiting the disclosed methods to performing the steps in that order. Rather, the various steps of each of the methods disclosed herein can be performed in any of a variety of sequences. In addition, as the described methods are merely exemplary embodiments, various other methods that include additional steps or include fewer steps are also within the scope of the present disclosure.

The instruments disclosed herein can be constructed from any of a variety of known materials. Exemplary materials include those which are suitable for use in surgical applications, including metals such as stainless steel, titanium, nickel, cobalt-chromium, or alloys and combinations thereof, polymers such as PEEK, ceramics, carbon fiber, and so forth. The various components of the instruments disclosed herein can be rigid or flexible. Device sizes can also vary greatly, depending on the intended use and surgical site anatomy. Furthermore, particular components can be formed from a different material than other components. One or more components or portions of the instruments can be formed from a radiopaque material to facilitate visualization under fluoroscopy and other imaging techniques, or from a radiolucent material so as not to interfere with visualization of other structures. Exemplary radiolucent materials include carbon fiber and high-strength polymers.

The instruments and methods disclosed herein can be used in minimally-invasive surgery and/or open surgery. While the instruments and methods disclosed herein are generally described in the context of spinal surgery on a human patient, it will be appreciated that the methods and instruments disclosed herein can be used in any type of surgery on a human or animal subject, in non-surgical applications, on non-living objects, and so forth.

The devices disclosed herein can be designed to be disposed after a single use, or they can be designed for multiple uses. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present invention.

The devices described herein can be processed before use in a surgical procedure. First, a new or used instrument can be obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument can be placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and its contents can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container can keep the instrument sterile until it is opened in the medical facility. Other forms of sterilization known in the art are also possible. This can include beta or other forms of radiation, ethylene oxide, steam, or a liquid bath (e.g., cold soak). Certain forms of sterilization may be better suited to use with different portions of the device due to the materials utilized, the presence of electrical components, etc.

All papers and publications cited herein are hereby incorporated by reference in their entirety. Although specific embodiments are described above, it should be understood that numerous changes may be made within the spirit and scope of the concepts described. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims

1. A surgical instrument, comprising:

a proximal end;

a distal end;

a central longitudinal axis extending between the proximal and distal ends;

a body;

a slider coupled to the body, the body and the slider collectively defining an implant clamp at the distal end of the instrument;

an actuation knob movable between a first position in which the clamp is configured to retain an implant to the instrument without allowing the implant to rotate relative to the instrument and a second position in which the clamp is configured to retain an implant to the instrument while allowing the implant to rotate relative to the instrument.

2. The instrument of claim 1, wherein the clamp is configured to selectively allow rotation of the implant about a rotation axis that is perpendicular to the central longitudinal axis.

3. The instrument of claim 2, further comprising a handle extending from the body such that a central longitudinal axis of the handle is transverse to the central longitudinal axis of the instrument;

wherein the rotation axis is perpendicular to a plane defined by the central longitudinal axis of the instrument and the central longitudinal axis of the handle.

4. The instrument of claim 1, further comprising a locking shaft coupled to a proximal end of the slider;

wherein a proximal end of the locking shaft includes a groove formed therein and a central portion of the locking shaft includes exterior threads formed thereon; and

wherein the locking shaft is received within a first bore formed in the body.

5. The instrument of claim 4, wherein the actuation knob includes a central opening having interior threads that mate with the exterior threads formed on the locking shaft.

6. The instrument of claim 4, further comprising an actuator disposed within a second bore formed in the body and configured to move between a first position to couple the locking shaft to the body and a second position to release the locking shaft from the body.

7. The instrument of claim 6, wherein the actuator is biased toward the first position.

8. The instrument of claim 6, wherein the actuator is configured to couple the locking shaft to the body by disposing a portion thereof within the groove formed in the locking shaft.

9. The instrument of claim 8, wherein the groove in the locking shaft is sized such that some degree of proximal and distal translation of the locking shaft relative to the actuator and the body is possible when the actuator is in the first position.

10. A surgical method, comprising:

coupling an implant to an inserter such that the implant cannot rotate relative to the inserter;

passing the implant through a working channel to a surgical site;

configuring the inserter to allow rotation of the implant relative to the inserter while still retaining the implant to the inserter;

articulating the implant while retained to the inserter; and

releasing the implant from the inserter.

11. The method of claim 10, wherein coupling the implant to the inserter includes moving an actuator of the inserter from a first position to a second position to allow a slider of the inserter to be withdrawn proximally relative to a body of the inserter and thereby open an implant clamp of the inserter defined by distal ends of the slider and the body.

12. The method of claim 11, wherein coupling the implant to the inserter further includes placing a portion of the implant within the implant clamp, advancing the slider distally relative to the body to close the implant clamp around the portion of the implant, moving the actuator to the first position to limit movement of the slider relative to the body, and rotating an actuation knob in a first direction to further advance the slider distally and lock the rotational position of the implant relative to the inserter.

13. The method of claim 12, wherein configuring the inserter to allow rotation of the implant relative to the inserter while still retaining the implant to the inserter includes rotating the actuation knob in a second direction to retract the slider proximally relative to the body.

14. The method of claim 13, wherein releasing the implant from the inserter includes moving the actuator from the first position to the second position and retracting the slider proximally relative to the body to open the implant clamp.

15. A surgical instrument, comprising:

a body having an elongate distal portion and a handle extending from a proximal portion of the body;

a slider coupled to the body and extending parallel to the elongate distal portion of the body, wherein distal ends of the slider and the body collectively define an implant clamp;

a locking shaft coupled to a proximal end of the slider and received within a first bore formed in the proximal portion of the body;

a first actuator disposed within a second bore formed in the proximal portion of the body, the first actuator being configured to selectively limit proximal and distal translation of the slider relative to the body;

a second actuator disposed about the locking shaft that is also configured to limit proximal and distal translation of the slider relative to the body;

wherein the first actuator and the second actuator can be configured to selectively retain an implant within the implant clamp and selectively allow rotation of the implant relative to the instrument.

16. The instrument of claim 15, wherein the clamp is configured to selectively allow rotation of the implant about a rotation axis that is perpendicular to a central longitudinal axis of the instrument extending between a proximal end of the body and the distal end of the body.

17. The instrument of claim 16, wherein the handle extends from the proximal portion of the body such that a central longitudinal axis of the handle is transverse to the central longitudinal axis of the instrument;

wherein the rotation axis is perpendicular to a plane defined by the central longitudinal axis of the instrument and the central longitudinal axis of the handle.

18. The instrument of claim 15, wherein the second actuator is a knob including a central opening having interior threads that mate with the exterior threads formed on the locking shaft.